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U.S. Department of Health and Human Services

Import Refusal Report

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Refusal Details as Recorded in OASIS by FDA

for Refusal J86-0316319-9/1/1

Manufacturer FEI1000265364
Manufacturer NameZenna Chemical Industry Co., Ltd.  
Manufacturer Address line 148 Yi Hsin 1 St. Road, Taipinghsiang,  
Manufacturer Address line 2  
Manufacturer's CityTaichung  
Manufacturer Province/State  
Manufacturer Country/AreaTaiwan  
Product Code53LC03  
Importer's Product DescriptionFACE CREAM(SAMPLES)  
Refusal Date30-Apr-2012  
FDA DistrictLOS-DO  
Entry/doc/line/sfx J86-0316319-9/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
NOT LISTED   502(o), 801(a)(3); MISBRANDING   It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).